Trial Outcomes & Findings for Amyloidopathy, Cholinopathy, Dopamine Responsiveness and Freezing of Gait in PD (NCT NCT03647137)
NCT ID: NCT03647137
Last Updated: 2024-01-05
Results Overview
Participants are considered as L-DOPA insensitive if their freezing of gait is not observed to be any different between motor assessment while on dopaminergic medication and off dopaminergic medication.
Recruitment status
COMPLETED
Target enrollment
53 participants
Primary outcome timeframe
through study completion, an average of 6 months
Results posted on
2024-01-05
Participant Flow
2 participants were excluded before assignment because they showed a normal dopaminergic PET brain scan prior to motor assessment. 7 participants were excluded before assignment because they didn't consent to being recorded on camera during motor assessment. Another 7 participants were dropped for showing normal dopaminergic scan after motor assesment, which precluded them from being assigned into groups.
Participant milestones
| Measure |
Parkinson's Disease Without FoG
Subjects with Parkinson's disease that do not have freezing of gait observed during motor assessment while both on or off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Only While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between on and Off Meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
10
|
7
|
|
Overall Study
Received DTBZ, PIB, and FEOVB PET Scan
|
11
|
6
|
9
|
5
|
|
Overall Study
COMPLETED
|
11
|
6
|
9
|
5
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Parkinson's Disease Without FoG
Subjects with Parkinson's disease that do not have freezing of gait observed during motor assessment while both on or off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Only While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between on and Off Meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
Overall Study
Scan Limitation
|
2
|
1
|
1
|
2
|
Baseline Characteristics
Amyloidopathy, Cholinopathy, Dopamine Responsiveness and Freezing of Gait in PD
Baseline characteristics by cohort
| Measure |
Parkinson's Disease Without FoG
n=11 Participants
Subjects with Parkinson's disease that do not have freezing of gait observed during motor assessment while both on or off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Only While Off-meds
n=6 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
n=9 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between On and Off-meds
n=5 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67.27 years
STANDARD_DEVIATION 5.81 • n=5 Participants
|
63.5 years
STANDARD_DEVIATION 8.57 • n=7 Participants
|
72.78 years
STANDARD_DEVIATION 6.96 • n=5 Participants
|
71.8 years
STANDARD_DEVIATION 6.94 • n=4 Participants
|
68.87 years
STANDARD_DEVIATION 7.46 • n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Only participants that have freezing of gait during either on or off meds motor assesment.
Participants are considered as L-DOPA insensitive if their freezing of gait is not observed to be any different between motor assessment while on dopaminergic medication and off dopaminergic medication.
Outcome measures
| Measure |
Participants With Freezing of Gait
n=20 Participants
L-DOPA insensitivity was assessed in a subset of participants that showed freezing of gait during either on or off medication motor examination.
|
Parkinson's Disease With FoG Only While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between On and Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
L-DOPA Insensitivity
|
5 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsParametric distribution volume ratio (DVR) of FEOVB, a cholinergic PET tracer, in the striatum.
Outcome measures
| Measure |
Participants With Freezing of Gait
n=11 Participants
L-DOPA insensitivity was assessed in a subset of participants that showed freezing of gait during either on or off medication motor examination.
|
Parkinson's Disease With FoG Only While Off-meds
n=6 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
n=9 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between On and Off-meds
n=5 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
Striatal FEOVB PET Binding
|
4.89 distribution volume ratio
Standard Deviation 0.7
|
5.01 distribution volume ratio
Standard Deviation 0.69
|
4.30 distribution volume ratio
Standard Deviation 0.81
|
4.06 distribution volume ratio
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsParametric distribution volume ratio (DVR) of DTBZ, a dopaminergic PET tracer, in the striatum.
Outcome measures
| Measure |
Participants With Freezing of Gait
n=11 Participants
L-DOPA insensitivity was assessed in a subset of participants that showed freezing of gait during either on or off medication motor examination.
|
Parkinson's Disease With FoG Only While Off-meds
n=6 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
n=9 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between On and Off-meds
n=5 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
Striatal DTBZ PET Binding
|
1.93 distribution volume ratio
Standard Deviation 0.36
|
1.76 distribution volume ratio
Standard Deviation 0.24
|
1.59 distribution volume ratio
Standard Deviation 0.20
|
1.76 distribution volume ratio
Standard Deviation 0.35
|
PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsParametric distribution volume ratio (DVR) of PIB, an amyloid PET tracer, in the striatum.
Outcome measures
| Measure |
Participants With Freezing of Gait
n=11 Participants
L-DOPA insensitivity was assessed in a subset of participants that showed freezing of gait during either on or off medication motor examination.
|
Parkinson's Disease With FoG Only While Off-meds
n=6 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
n=9 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between On and Off-meds
n=5 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
Striatal PIB PET Binding
|
1.08 distribution volume ratio
Standard Deviation 0.11
|
1.15 distribution volume ratio
Standard Deviation 0.08
|
1.12 distribution volume ratio
Standard Deviation 0.12
|
1.02 distribution volume ratio
Standard Deviation 0.07
|
SECONDARY outcome
Timeframe: through study completion, an average of 6 monthsPopulation: Limited subset of participants that underwent a serotonergic DASB PET scan.
Serotonergic innervation of striatum as assessed by DASB PET scan across freezer groups.
Outcome measures
| Measure |
Participants With Freezing of Gait
n=1 Participants
L-DOPA insensitivity was assessed in a subset of participants that showed freezing of gait during either on or off medication motor examination.
|
Parkinson's Disease With FoG Only While Off-meds
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment only while off dopaminergic medication who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Worse While Off-meds
n=1 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, but greater severity of FoG under off-med, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
Parkinson's Disease With FoG Equivalent Between On and Off-meds
n=1 Participants
Subjects with Parkinson's disease that have freezing of gait observed during motor assessment while both on and off dopaminergic medication, with no apparent effect of dopaminergic medication on FoG, who have undergone Brain PET imaging of 11C-DBTZ, 18F-FEOBV (vesicular acetylcholine transporter, and 11C-PIB (beta-amyloid).
|
|---|---|---|---|---|
|
Serotonergic Innervation of Striatum and Freezing
|
1.741856 Parametric DVR
|
—
|
1.120202 Parametric DVR
|
1.796165 Parametric DVR
|
Adverse Events
Parkinson's Disease Without FoG
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parkinson's Disease With FoG Only While Off-meds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parkinson's Disease With FoG Worse While Off-meds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parkinson's Disease With FoG Equivalent Between On and Off-meds
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place